Model note · Cryotherapy System
Medtronic Arctic Front Cardiac CryoAblation Catheter
Arctic Front is Medtronic's cryoballoon system for pulmonary vein isolation in atrial fibrillation. The CryoConsole injects liquid nitrous oxide through a coaxial umbilical and the catheter shaft into a balloon held under vacuum, then returns the gas and vents it to hospital suction or evacuation. Biomedical teams look after the console, its refrigerant tank, umbilicals and the scavenging connection, while the balloon catheters are single use.
The model
Maker, model and type.
- Maker
- Medtronic CryoCath LP (Medtronic plc)
- Model
- Arctic Front Cardiac CryoAblation Catheter with CryoConsole (106A2 family)
- Device type
- Cryotherapy System
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Refrigerant | Pressurised liquid nitrous oxide (N2O) from a tank inside the CryoConsole | Source |
| Gas return | Balloon kept under vacuum; exhaust goes to the hospital suction or evacuation system | Source |
| Original balloon catheters | 2AF232 (23 mm balloon) and 2AF282 (28 mm balloon), deflectable, over the wire | Source |
| Adjunct focal catheter | Freezor MAX 239F3 (55 mm reach) and 239F5 (66 mm reach) | Source |
| Console accessories | Coaxial umbilical, electrical umbilical, auto connection box, ECG cable, footswitch; Manual Retraction Kit 20MRK as backup for balloon inflation and deflation | Source |
| Delivery sheath | FlexCath Steerable Sheath (K081049) | Source |
| Leak and blood detection | Bench testing led to a recommended 30 second pre injection delay for the leak and blood detection system | Source |
| Console model variants in a 2015 recall | 106A3, 106E2 and 106A2-K | Source |
| FDA approval | PMA P100010, approved 17 December 2010, for drug refractory recurrent symptomatic paroxysmal AF | Source |
Recalls
Known FDA recalls.
- Z-2777-20152015-09-01
USB memory component in some CryoConsoles (106A3, 106E2, 106A2-K) could extend procedure time.
FDA record - Z-0149-20122011-08-29
Some Arctic Front 2AF282 lots programmed incorrectly, giving false expired catheter notices.
FDA record
Safety
Safety warnings from the record.
- Arctic Front is contraindicated in the ventricle because of the risk of entrapment in chordae, and in patients with pulmonary vein stents or cryoglobulinaemia. Source
- Persistent phrenic nerve palsy, pulmonary vein stenosis and atrio oesophageal fistula were tracked as primary safety events in the pivotal study. Source
- Used nitrous oxide is returned to the console and evacuated to hospital suction or evacuation, so the scavenging connection is part of safe set up. Source
Sources
Where this note comes from.
- FDA PMA P100010 Summary of Safety and Effectiveness Data, Arctic Front and CryoConsole
- openFDA recall search, CryoConsole
- openFDA MAUDE problem counts, brand CRYOCONSOLE
Not covered: Specs come from the 2010 PMA summary for the first generation catheter and CryoConsole 106A2; Arctic Front Advance and Advance Pro changes were approved as supplements whose summaries were not read. The CryoConsole operator and service manuals are not public, so no console error codes, tank changing steps or part numbers are given. Balloon temperature figures are not stated as a console specification in the public summary. The res.cfm recall pages returned errors on reopening, so recall text is from openFDA records. The manufacturerUrl is Medtronic's home page.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Cryotherapy System
Other models of this device.
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