MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. CLARIFIX; CRYOSURGICAL UNIT AND ACCESSORIES

Model Number	CFX-2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Epistaxis (4458)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one week after the patient was treated with the cryotherapy device the patient started experiencing epistaxis and two week after the procedure the patient had severe epistaxis and was treated with electrocoagulation.The bleeding was reported to be coming from the branch of the sphenopalatine artery, which was located at the treatment site.No additional epistaxis has occurred and no permanent damage was reported.
Additional Manufacturer Narrative
H3 other text : device discarded after procedure.

• Brand Name: CLARIFIX
• Common Device Name: CRYOSURGICAL UNIT AND ACCESSORIES
• Manufacturer (Section D): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer (Section G): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer Contact: colette chung ; 3600 holly lane north; suite 40; plymouth, MN 55447 ; 7634637066
• MDR Report Key: 16965190
• Report Number: 3006345872-2023-00007
• Device Sequence Number: 5238484
• Product Code: GEH
• UDI-Device Identifier: 00850002250404
• UDI-Public: 00850002250404
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: CFX-2000
• Device Catalogue Number: CFX-2000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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