# K163684: C2 CryoBalloon Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: C2 Therapeutics, Inc.
- Decided: Jan 23, 2018 after 391 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K943450 (1995). 69 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161202: C2 Cryoballoon Ablation System, C2 Therapeutics, Inc. (2017). Cleared while this submission was under review Summary page 4.
- K152329: Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System, C2 Therapeutics, Inc. (2016) Summary page 4.

## Most influential descendants
- K190194: C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge (2019), 3 descendants of its own
- K203024: C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge (2020), 2 descendants of its own
- K212814: C2 CryoBalloon Ablation System (2021), 1 descendant of its own
- K240457: C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) (2024), 0 descendants of its own

## Recalls of this device
- Dec 3, 2018 · Class II · Z-0970-2019: The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen 
- Dec 3, 2018 · Class II · Z-1326-2019: Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
- Dec 3, 2018 · Class II · Z-1327-2019: Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
- Dec 3, 2018 · Class II · Z-1325-2019: Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.

## Indications for use
The C2 CryoBalloon™ Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett’s Esophagus with dysplasia.

Source page: https://510kreport.com/device/K163684
Methodology: https://510kreport.com/methodology