510(k) Report

510(k) · Cleared

Cleared

Cryoballoon Ablation System

K101825510(k) TraditionalCleared Sep 29, 201090-day reviewClass II21 CFR 878.4350

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

C2 Therapeutics · GEH Unit, Cryosurgical, Accessories

Cleared on Sep 29, 2010 as substantially equivalent to K060555 (Crymed Technologies, Inc., 2006) and 3 other predicates after a 90-day review. Its family tree reaches back 5 generations to 1984. 11 later devices descend from it.

Decided
Sep 29, 2010
Review
90 days
Class
Class II
Product code
GEH
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K840536 (1984). 11 ancestors in all, the oldest K811390 (1981). 11 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2002: 1 other ancestor1998: 1 other ancestor1994: 1 other ancestor1981: 2 other ancestors2013: 1 descendant cleared2015: 1 descendant cleared2016: 3 descendants cleared2017: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant clearedK840536 · Cryo Surg 5900 · Frigitronics of Connecticut, Inc. · 1984K970995 · CMS Cryolite · Cryomedical Sciences, Inc. · 1997K040809 · Crymed Cryo-Ablator · Crymed Technologies, Inc. · 2004K060555 · Spraygenix Cryo Ablation System · Crymed Technologies, Inc. · 2006K070893 · Cryospray Ablation System, Model CU 8407020500 · CSA Medical, Inc. · 200719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant7 generations forward: 1 descendant K070893 · Cryospray Ablation System, Model CU 8407020500 · CSA Medical, Inc. · 2007K060555 · Spraygenix Cryo Ablation System · Crymed Technologies, Inc. · 2006K040809 · Crymed Cryo-Ablator · Crymed Technologies, Inc. · 2004K970995 · CMS Cryolite · Cryomedical Sciences, Inc. · 1997K840536 · Cryo Surg 5900 · Frigitronics of Connecticut, Inc. · 1984−50+5
  1. Root · 5 generations backK840536 Cryo Surg 5900Frigitronics of Connecticut, Inc. · 1984
  2. 4 generations backK970995 CMS CryoliteCryomedical Sciences, Inc. · 1997
  3. 3 generations backK040809 Crymed Cryo-AblatorCrymed Technologies, Inc. · 2004
  4. 2 generations backK060555 Spraygenix Cryo Ablation SystemCrymed Technologies, Inc. · 2006
  5. 1 generation backK070893 Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc. · 2007
  6. This deviceK101825 Cryoballoon Ablation SystemC2 Therapeutics · 2010
  7. Descendant · cites it directly · 10 of its ownK131523 Cryoballoon Focal Ablation SystemC2 Therapeutics · 2013 · Recalled
  8. Descendant · 2 generations on · 8 of its ownK151054 Coldplay Full CryoBalloon Ablation System and Coldplay Swipe…C2 Therapeutics, Inc. · 2015
  9. Descendant · 2 generations on · 6 of its ownK152329 Coldplay Cryoballoon; Focal Ablation System, Full Ablation System…C2 Therapeutics, Inc. · 2016 · Recalled
  10. Descendant · 3 generations on · 5 of its ownK161202 C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc. · 2017 · Recalled
  11. Descendant · 3 generations on · 4 of its ownK163684 C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 2018 · Recalled

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2013: 12015: 12016: 32017: 12018: 12019: 12020: 12021: 12024: 1
2013high 3 (2016) · low 0 (2014)2026

Most influential descendants

Showing 5 of 11 · See all
  • K131523Cryoballoon Focal Ablation SystemC2 Therapeutics · 2013 · cites it directly10descendants
  • K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 2015 · 2 generations on8descendants
  • K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc. · 2016 · 2 generations on6descendants
  • K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc. · 2017 · 3 generations on5descendants
  • K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 2018 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K840536Cryo Surg 5900Frigitronics of Connecticut, Inc.1984—
−4K970995CMS CryoliteCryomedical Sciences, Inc.1997—
−3K040809Crymed Cryo-AblatorCrymed Technologies, Inc.2004—
−2K060555Spraygenix Cryo Ablation SystemCrymed Technologies, Inc.2006—
−1K070893Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc.2007—
0 (this device)K101825Cryoballoon Ablation SystemC2 Therapeutics2010—
+1K131523Cryoballoon Focal Ablation SystemC2 Therapeutics20132
+2K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon…C2 Therapeutics, Inc.2015—
+2K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe…C2 Therapeutics, Inc.20161
+3K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.20171
+3K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.20184

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198120
199410
199810
200210
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201510
201630
201710
201810
201910
202010
202110
202410
FIG. 1 — Lineage of K101825, 1984–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEH device

  1. #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K060555Spraygenix Cryo Ablation System
Summary page 1
…balloon probe and accessories III. Predicate Devices * CryMed Technologies SprayGeniXTm Ablation System - K060555 * CSA Medical CryoSpray Ablation System - K070893 * GI Supply Polar Wand Cryotherapy System - K021387…
Crymed Technologies, Inc.2006—
*K070893Cryospray Ablation System, Model CU 8407020500
Summary page 1
…e and accessories III. Predicate Devices * CryMed Technologies SprayGeniXTm Ablation System - K060555 * CSA Medical CryoSpray Ablation System - K070893 * GI Supply Polar Wand Cryotherapy System - K021387 * Barrx Medical HALO360 Coagulation System - K05 1168. I…
CSA Medical, Inc.2007—
*K021387Polar Wand
Summary page 1
…Med Technologies SprayGeniXTm Ablation System - K060555 * CSA Medical CryoSpray Ablation System - K070893 * GI Supply Polar Wand Cryotherapy System - K021387 * Barrx Medical HALO360 Coagulation System - K05 1168. IV. Product Description The CryoBalloon Ablati…
Chek-Med Systems2002—
*K051168Barrx Halo 360 System, Model 1100C-115A
Summary page 1
…* CSA Medical CryoSpray Ablation System - K070893 * GI Supply Polar Wand Cryotherapy System - K021387 * Barrx Medical HALO360 Coagulation System - K05 1168. IV. Product Description The CryoBalloon Ablation System ("System") is used to destroy unwanted tissue by…
Barrx Medical, Incorporated2005—

Also cleared against K060555: 3 other devices →

What descends from it? (11)

See all 11

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131523Cryoballoon Focal Ablation SystemC2 Therapeutics201310

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
  • None of the 11 ancestors has a recall.
  • Of its descendants, K131523 (C2 Therapeutics, 2013) has gone furthest, with 10 descendants of its own.
  • 3 other devices also cite its predicate K060555.

How does its category compare?

All GEH devices

GEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · GEH

10in 2025

2007: 62008: 12009: 42010: 42011: 72012: 42013: 42014: 62015: 112016: 152017: 122018: 62019: 62020: 82021: 62022: 62023: 82024: 92025: 102026 (partial year): 8
2007high 15 (2016) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEH

77in 2025

2007: 71 days median2009: 121 days median2010: 86 days median2011: 91 days median2012: 96 days median2013: 76 days median2014: 42 days median2015: 72 days median2016: 60 days median2017: 83 days median2018: 42 days median2019: 115 days median2020: 113 days median2021: 206 days median2022: 56 days median2023: 136 days median2024: 85 days median2025: 77 days median2026 (partial year): 148 days median
2007high 206 (2021) · low 42 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEH

2in 2023

2007: 32008: 22009: 132010: 42012: 32014: 22018: 12019: 12020: 372023: 22026 (partial year): 2
2007high 37 (2020) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GEH

171in 2025

2007: 232008: 292009: 212010: 1732011: 612012: 912013: 912014: 572015: 972016: 1432017: 2162018: 2082019: 4552020: 2772021: 2132022: 2302023: 1642024: 1412025: 171
2007high 455 (2019) · low 21 (2009)2025

MAUDE reports naming product code GEH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007671323
20081—229
200941211321
20104864173
2011791061
2012496391
2013476091
2014642257
20151172097
201615600143
201712830216
20186421208
201961151455
2020811337277
202162060213
20226560230
202381362164
20249850141
202510770171
202681482—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

Also cleared against K060555

3 other devices cite the same predicate.

  • K113021Trufreeze System, Trufreeze Spray KitCSA Medical, Inc. · 2012
  • K072651Cryospray Ablation System, Model CC2-NamCSA Medical, Inc. · 2007
  • K070893Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc. · 2007

More from C2 Therapeutics

3 FDA decisions under this applicant name. See the company

  • K150083Sidecar External Working ChannelC2 Therapeutics · 2015
  • K131523Cryoballoon Focal Ablation SystemC2 Therapeutics · 20132 recalls

Recent decisions in GEH

The GEH category page

  • K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex Medical · 2026
  • K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex Medical · 2026
  • K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbH · 2026
  • K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbH · 2026
  • K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V. · 2026

https://510kreport.com/device/K101825 · printed Nov 4, 2026

Cite this page

510(k) Report. “K101825: Cryoballoon Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101825

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026