# K101825: Cryoballoon Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: C2 Therapeutics
- Decided: Sep 29, 2010 after 90 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K840536 (1984). 11 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060555: Spraygenix Cryo Ablation System, Crymed Technologies, Inc. (2006) Summary page 1.
- K070893: Cryospray Ablation System, Model CU 8407020500, CSA Medical, Inc. (2007) Summary page 1.
- K021387: Polar Wand, Chek-Med Systems (2002) Summary page 1.
- K051168: Barrx Halo 360 System, Model 1100C-115A, Barrx Medical, Incorporated (2005) Summary page 1.

## Most influential descendants
- K131523: Cryoballoon Focal Ablation System (2013), 10 descendants of its own
- K151054: Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System (2015), 8 descendants of its own
- K152329: Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System (2016), 6 descendants of its own
- K161202: C2 Cryoballoon Ablation System (2017), 5 descendants of its own
- K163684: C2 CryoBalloon Ablation System (2018), 4 descendants of its own

## Indications for use
The C2 Therapeutics CryoBalloon Ablation System is intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.

Source page: https://510kreport.com/device/K101825
Methodology: https://510kreport.com/methodology