MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP CLARIFIX; CRYOSURGICAL UNIT AND ACCESSORIES

Catalog Number	CFX-2000
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Codes	Perforation (2001); Epistaxis (4458); Cryogenic Burn (4539)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during cryotherapy inside patient's nasal cavity the cryogen flow could not be stopped and caused severe tissue damage including tearing of mucosal tissue, bleeding and exposure of bone.Intervention was necessary with repair of the tissue using multiple unplanned products.The patient is doing well after intervention on follow-up appointment with the surgeon.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.The quality investigation is complete, codes have been updated.
Event or Problem Description
No new information.

• Brand Name: CLARIFIX
• Common Device Name: CRYOSURGICAL UNIT AND ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; suite 40; portage MI 49002
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 23313963
• Report Number: 3006345872-2025-00013
• Device Sequence Number: 5802270
• Product Code: GEH
• UDI-Device Identifier: 00850002250404
• UDI-Public: (01)00850002250404(11)250403(17)270401(10)25093083
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K190356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CFX-2000
• Device Lot Number: 25093083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown