MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. CLARIFIX; Unit, Cryosurgical, Accessories

Catalog Number	CFX2000
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 10 events were reported for this quarter.Product return status: 10 devices had investigation types that have not yet been determined.Evaluation findings (results/components): 10 devices: results pending completion of investigation / part/component/sub-assembly term not applicable.Product disposition: 10 devices: product disposition is not yet determined.Additional information: 10 devices were labeled for single-use.10 devices were not reprocessed or reused.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between january 1 ¿ march 31 2026.This report summarizes 10 events for the failure: free or unrestricted flow.10 events had no health consequences or impact.

• Brand Name: CLARIFIX
• Common Device Name: Unit, Cryosurgical, Accessories
• Manufacturer (Section D): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer (Section G): Stryker Instruments-Kalamazoo; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; +1(269)323-7700
• MDR Report Key: 24954401
• Report Number: 3015967359-2026-99310
• Device Sequence Number: 17494435
• Product Code: GEH
• UDI-Device Identifier: 00850002250404
• UDI-Public: 00850002250404
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 9
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CFX2000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 03/31/2026; 03/31/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 07/20/2026; 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown